Tag:Regulation
Johnson & Johnson COVID-19 Vaccine Awaits Authorization from FDA
Recently, the U.S. Food & Drug Administration (“FDA”) announced a scheduled meeting of its Vaccines and Related Biological Products Advisory Committee (“VRBPAC”) to discuss the request for emergency use authorization (“EUA”) for a COVID-19 vaccine from Janssen Biotech Inc. The FDA has just under three weeks to complete its report before the VRBPAC’s meeting to make its recommendation on the vaccine. The review process may be more challenging than the past two reviews for Pfizer and Moderna due to the composition differences and effectiveness.
The Clean Water Act: The Broadening of the National Pollutant Discharge Elimination System Permitting Program to Regulate Indirect Discharge Through Groundwater
On January 14, 2021, the United States Environmental Protection Agency (“EPA”) issued a Guidance Memorandum (hereinafter “Memo”) addressing the recent decision of the Supreme Court of the United States in the case County of Maui v. Hawai’i Wildlife Foundation, 140 S. Ct. 1462 (2020) regarding the regulation of water pollution under the Clean Water Act (CWA or “the Act”). The Memo outlined how the Court’s recent ruling in the County of Maui applies to the National Pollutant Discharge Elimination System (“NPDES”) permit program created under Section 402 of the Clean Water Act (hereinafter “Section 402”). The intent of the EPA in publishing the Memo is to help clarify the effect of the Court’s ruling in County of Maui for owners and operators of facilities subject to the regulation of the CWA, the primary regulatory framework for governing water pollution in the United States. The ruling in County of Maui expands the types of discharge that are subject to the CWA’s regulatory permit program and illuminates the steps required of facility owners and operators to comply with that framework.
Final Rule and Updates to Non-discrimination Regulations of the ACA
The Department of Health and Human Services (“HHS”) finalized revised regulations that implemented Section 1557 of the Affordable Care Act (“ACA”) in June of 2020. This section prohibits discrimination within health programs and activities receiving federal financial assistance based on race, color, sex, age, disability, and national origin. In comparison to the Obama-era regulations issued in 2016, the new final rule does away with gender identity and sexual orientation nondiscrimination protections not only under Section 1557, but under ten other federal regulations as well. This also includes a roll back of certain health insurance coverage protections for transgender individuals.
One of Wall Street’s Hottest Trends: The SPAC
SPACs have been around for decades and often existed as last resorts for small companies that would have otherwise had trouble raising money on the open market. But they’ve recently become more prevalent because of the extreme market volatility caused, in part, by the global pandemic.
While many companies chose to postpone their IPOs due to the pandemic, others chose the alternate route to an IPO by merging with a SPAC. A SPAC merger allows a company to go public and get a capital influx more quickly than it would have with a conventional IPO.
Re-Regulating the Automotive Industry & the Road Ahead
A new President and a changing administration mean new priorities across some, if not all of the major executive agencies. One of the more heavily impacted industries will be transportation—specifically the automotive sector. From re-instating stricter emissions standards to moving forward with automated vehicle regulations, the automotive industry in the early 2020s should see innovation and progress at the forefront of the country’s new federal regulatory scheme.
President Biden’s COVID-19 Data-Driven Executive Order to Promote Health Equity
President Joe Biden has issued a number of Executive Orders, many of which address the ongoing COVID-19 public health emergency. On January 21, 2021, President Biden released another pillar of his Administration’s long-term plan to direct the United States out of the throes of the pandemic. The twelfth Executive Order titled, “Ensuring a Data-Driven Response to COVID-19 and Future High-Consequence Public Health Threats” orders the Department of Health and Human Services (“HHS”) Secretary Alex Azar to conduct a nationwide review of the interoperability of public health data systems in an effort to enhance the collection, sharing, analysis, and collaboration of de-identified patient data.
Market Regulation Issues Raised by the Gamestop Buying Frenzy
The regulation of hedge funds has largely been unchecked allowing big Wall Street players to manipulate the market for the benefit and at the detriment of other investors. But forced by an unprecedented movement of retail investors, Wall Street is being forced to reckon with the hypocrisy of their practices.
The Lack of Support the Payment Protection Program Has Given to Restaurants
We are now in the heart of winter, and many restaurants have not made it since Covid first shut-down Chicago in March 2020. When dining resumed in June, it came back as outdoor only. However the fear was, what would happen once it cooled down and outdoor dining wasn’t feasible? Chicago, like many other cities, has had to be creative and many restaurants have made it work. From dining igloos and greenhouses, to shutting down streets for more patio space, Chicago has been very creative. For the restaurants that have managed to survive, it has not been an easy path. The restaurant industry has been hit especially hard compared to other businesses, and they are not receiving the same protections and support as other industries. The Paycheck Protection Program (“PPP”) was designed to support small businesses, however restaurants have not been protected as they should have been.
Bitcoin, Tesla, and GameStop: Regulatory Challenges Posed by the New Retail Investor
GameStop started 2021 with a stock price below $20 but saw its stock price skyrocket to well above $300 a share towards the end of January. The rally would be hard to explain by solely relying on the company’s financial reports or underlying fundamentals. Instead, the rally has to be explained through a combination of external factors involving a popular fintech company’s app, manic speculation by retail investors, and Reddit. Although at first glance this may seem like a new phenomenon, the same factors have been at play for years with a huge interest in Tesla and Bitcoin – and they pose a risk to the markets that regulators and Wall Street together can’t ignore.
Vertical Healthcare Companies Merging Compliance Programs
Vertical Healthcare Companies Merging Compliance Programs Perri Nena Smith Senior Editor Loyola University Chicago School of Law, JD 2021 In 2020, The Federal Trade Commission (“FTC”) and the Department of Justice (“DOJ”) released guidelines for vertical mergers to give clarity to companies so they can avoid harmful mergers. Healthcare companies are an industry that has been …
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